Senior analytical/stability scientist with CMC documentation skills
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Are you passionate about improving lives of millions of people by supporting all our marketed products?
This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. LEO Pharma Global Research and Development devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema as well as supporting LEO Pharma marketed products within dermatology and thrombosis. You will enter Pharmaceutical Design and Development, Global R&D, at the most exciting period as we right now are transforming R&D and our marketed portfolio to meet the requirements of tomorrow.
Great opportunity within analytical support, CMC documentation for Market Approvals, and project management
Pharmaceutical Product Support Area is part of Global R&D, counting 45 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical, analytical, stability and primary packaging support for all marketed products at LEO Pharma.
You will join 15 enthusiastic and dedicated colleagues in the CMC MA Support department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products, and our most important internal stakeholder is Regulatory Affairs.
You will be part of a Product group and will be responsible for a minor portfolio of marketed products. You will have a counterpart in the CMC Stability Support department and it is expected that you to some extent can support in setting up stability studies according to ICH and other relevant guidelines, be a part of OOS investigations and perform analytical and chemical trouble shooting, mainly for small molecules.
Our values are impact, courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives many unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be part of the department responsible for answering authority questions regarding analytical and stability issues, maintaining and creating new module 3 documentation and set the response strategy together with our Pharmaceutical Experts and Regulatory Affairs. To some extent you will also be part of Life cycle management projects and lead smaller projects where your great stakeholder management skills will come into play.
As a part of your daily tasks you will be expected to be:
Answering authority questions Writing and updating module 3 documentation for regulatory purposes in connection with maintenance and projects Part of renewals and preparation of new MA´s Managing and participating in projects across the LEO organization globally Setting up stability studies, planning and executing analytical development and validation and contribute to OOS investigations As LEAN is an integral part of our continuous improvement journey you are also expected to drive or participate in smaller improvement initiatives
The ideal candidate:
The ideal candidate is a team player with strong collaboration skills, outgoing, tolerant and open-minded. You have a can-do attitude and are responsible, flexible, and a competent decision-maker.
Your experience and competences:
Master of Science in e.g. Pharmacy, Engineering or Chemistry perhaps in combination with a PhD Minimum of 5 years of experience working with CMC documentation within analytical chemistry and stability testing, Minimum of 3-5 years of experience as an analytical/stability chemist You are capable of analyzing and reducing complex issues and you are a person who thrives in significantly improving, changing or adapting existing processes, systems or products Experience with managing projects and coordinating tasks Good communication skills (English and Danish/Scandinavian) A solid experience with GMP will be considered an advantage as we work in accordance with current GMP regulations Experience with regulatory requirements, pharmacopoeias and guidelines Preferably LEAN experience or experience with continuous improvements
This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. LEO Pharma Global Research and Development devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema as well as supporting LEO Pharma marketed products within dermatology and thrombosis. You will enter Pharmaceutical Design and Development, Global R&D, at the most exciting period as we right now are transforming R&D and our marketed portfolio to meet the requirements of tomorrow.
Great opportunity within analytical support, CMC documentation for Market Approvals, and project management
Pharmaceutical Product Support Area is part of Global R&D, counting 45 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical, analytical, stability and primary packaging support for all marketed products at LEO Pharma.
You will join 15 enthusiastic and dedicated colleagues in the CMC MA Support department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products, and our most important internal stakeholder is Regulatory Affairs.
You will be part of a Product group and will be responsible for a minor portfolio of marketed products. You will have a counterpart in the CMC Stability Support department and it is expected that you to some extent can support in setting up stability studies according to ICH and other relevant guidelines, be a part of OOS investigations and perform analytical and chemical trouble shooting, mainly for small molecules.
Our values are impact, courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives many unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be part of the department responsible for answering authority questions regarding analytical and stability issues, maintaining and creating new module 3 documentation and set the response strategy together with our Pharmaceutical Experts and Regulatory Affairs. To some extent you will also be part of Life cycle management projects and lead smaller projects where your great stakeholder management skills will come into play.
As a part of your daily tasks you will be expected to be:
The ideal candidate:
The ideal candidate is a team player with strong collaboration skills, outgoing, tolerant and open-minded. You have a can-do attitude and are responsible, flexible, and a competent decision-maker.
Your experience and competences:
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 8.7.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Ballerup
- Fredag den 20. september 2019
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